Senior Quality Control Scientist at King’s College

Position Overview

Job Title: Senior Quality Control Scientist
Location: London
Salary: £34,189 to £40,792 per annum (inclusive of London Weighting Allowance)
Hours: Full Time
Contract Type: Permanent
Placed On: 5th July 2024
Closes: 10th July 2024
Job : 092217

King’s College London is seeking a dedicated and experienced Senior Quality Control (QC) Scientist to join our Cell and Gene Therapy (CGT) group. The successful candidate will play a critical role in performing in-house quality control testing for cell and gene therapy products, ensuring adherence to GLP, GMP, and ICH guidelines. This role encompasses the development, validation, and establishment of cutting-edge QC assays, collaboration with external partners, and the supervision of QC team members.

• Quality Control Testing: Conduct QC tests on final products, drug substances, and in-process samples using methods such as flow cytometry, cell proliferation assays, protein assays, western blots, and QPCR.
• Documentation and Compliance: Maintain accurate documentation of test results in compliance with the Pharmaceutical Quality System (PQS), ensuring data integrity. Review testing performed by other QC scientists.
• Assay Development and Validation: Design and validate QC assays in accordance with ICH Q2, GLP, and GMP guidelines. Lead the development of new assays and facilitate the tech transfer of collaborator/client assays into the CGT group.
• Raw Material and Stability Testing: Oversee testing of incoming raw materials and critical manufacturing materials, establishing reference standards where necessary. Maintain stability programs in collaboration with the Head of Quality.
• Audit Participation and Reporting: Engage in internal and external audits, initiate Out-of-Specification (OOS) and deviation reports/investigations, and support batch release timelines. Establish a system for trending QC test results and report findings quarterly.

• Proven experience in performing QC testing and stability assessments of final products, drug substances, and in-process samples in accordance with predefined specifications and GMP/GLP guidelines.
• Proficiency in using various testing methods, including flow cytometry, cell proliferation assays, protein assays, western blots, and molecular techniques like QPCR.
• Strong documentation skills, adhering to PQS and data integrity principles. Ability to review and ensure the accuracy of testing conducted by team members.
• Expertise in designing and validating QC assays, leading the development of new assays, and managing tech transfers.
• Experience in raw material testing and establishing stability programs, with the ability to supervise and support QC team members.

• Ability to draft clear and comprehensive experimental protocols.
• Hands-on experience with microbiological environmental monitoring.
• Engagement with external meetings related to GLP compliance and QC assay development for ATMPs.
• Ability to establish and report on QC testing trends to senior management.
• Flexibility to perform additional QC-related tasks as required.

To apply for this role, please submit your application by 10th July 2024
. We look forward to receiving your application and potentially welcoming you to our team at King’s College London.

For more information, please refer to Job .